Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Comparison of CT Derived CACS and Tomosynthesis Scores Correlation
研究概览
简要总结
The purpose of this study is to propose a new method for evaluating coronary artery calcium scores (CACS) in individuals with coronary artery disease.
详细描述
The proposed research, if successfully implemented, will result in a new method for evaluating coronary artery calcium scores (CACS) in individuals with coronary artery disease. Using the Cardiac Gated Stationary Chest Tomosynthesis (CG-SDCT) system the imaging dose for a a full tomosynthesis scan is expected to be only 10% of that from a low-dose CT. The targeted imaging time of 25-30 seconds is 1/2 of that from a current commercial DCT system at the same imaging dose. As with current commercial DCT systems, our s-DCT system will expose patients to less radiation and deliver comparable data for CACS. CG-SDCT will likely result in accurate CAC scoring and allow for a more complete patient risk assessment as compared to Framingham risk scoring alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: ≥18 years of age
- •Intermediate Framingham Risk Score of 10 to 20% risk over the next 10 years
- •Previous non-contrast enhanced chest CT in a time frame that will accommodate experimental imaging (CG-SDCT) within 4 weeks. This imaging may have already been completed at the time of enrollment or may be scheduled in the future at the time of enrollment.
- •IRB written informed consent obtained and signed Exclusion Criteria
- •Negative urine pregnancy test in women of child-bearing potential (WCBP) within 1 week prior to s-DCT.
排除标准
- •Unable to provide consent
- •Pregnant or lactating
- •BMI > 33 (Patient who may not fit on a 35 x 35 detector) (Images are not clear on subjects who have a greater than 33 BMI)
- •Previous history of MI or thoracic surgery.
- •Disability that could interfere with the scanning process, non-ambulatory or unable to hold their breath for up to 30 seconds.
- •Planned procedures or therapies in between non-contrast CT scan and study Chest tomosynthesis scan, e.g., line placement in the chest region, biopsy, etc.
结局指标
主要结局
Comparison of CT Derived CACS and Tomosynthesis Scores Correlation
时间窗: 1 year
Linear regression and Bland-Altman analysis will be used to examine the relationship between the CT derived CACS and tomosynthesis scores to determine the correlation
次要结局
- Mean Correlation Coefficient of Gating(At the conclusion of all data collection, 6 months post study completion)